CTRI/2024/06/069035RecruitingPhase 3
Effectiveness of slow cortical potential neurofeedback in comparison to stimulant medication methylphenidate on behavioral outcomes in children with attention deficit hyperactivity disorder.
Ritambhara Mandal1 site in 1 country60 target enrollmentStarted: June 25, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Neurofeedback is effective on behavioural outcomes of ADHD in comparison to stimulant medication ,according to conners 3 parent short scale
Study Overview
Brief Summary
This study is a randomized , parallel group trial where 60 childrens diagnosed with ADHD will be divided into two groups, one group will receive neurofeedback along with stimulant medication and another group will receive only stimulant medication that is methylphenidate . There will be 24 sessions and each session will be of 16 minutes .follow up will be done after 3 months as per conners 3 parent short scale . Primary outcome measures how much effective the neurofeedback is in comparison to stimulant medication.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Aged 6 to 12 years 2) Fulfilling the diagnostic criteria according to DSM 5 3)Fulfilling the criteria of CONNERS 3AI, ADHD Indicator scale as screening tool 4) Children with no contraindication for methylphenidate 5) parents are willing to give informed consent on behalf of their children and compliant to therapy.
Exclusion Criteria
- •Children with Intellectual deficit disorder and Autism spectrum disorder 2) Any neurological like seizure disorder or physical illness 3) Any other significant psychiatric illness like mood disorder ,psychosis ,obsessive compulsive disorder.
Outcomes
Primary Outcomes
Neurofeedback is effective on behavioural outcomes of ADHD in comparison to stimulant medication ,according to conners 3 parent short scale
Time Frame: 3 months
Secondary Outcomes
- Neurofeedback improves inattention, hyperactivity, impulsivity, executive function, defiance or aggression and peer relation in children with ADHD(3 months)
Investigators
Ritambhara Mandal
Institute of Psychiatry
Study Sites (1)
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